CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 182 enrolled
Drug / intervention
60 µg dose hepatitis B vaccine +1 morebiological
Likely dose
60 µg dose hepatitis B vaccinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03316807
NCT03316807Phase 4Completed
CompareCT.gov

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China

Suping Wang·interventional·Posted Oct 20, 2017·Updated Mar 11, 2022

In Brief

A Phase 4 clinical trial evaluating 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine for Hepatitis B Vaccine. Completed, enrolled 182 participants.

Detailed Summary

Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge. This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccine
Countries--
CollaboratorsCenters for Disease Control and Prevention, China

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartOct 1, 2014
Primary CompletionJul 1, 2015
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.7 years ago

Interventions

60 µg dose hepatitis B vaccinebiological

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccinebiological

three-dose, 20 µg per dose